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`United Therapeutics, IPR2021-00406United Therapeutics, IPR2021-00406
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`·1· · · · · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3· ·----------------------------------------x
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`·4· ·LIQUIDIA TECHNOLOGIES, INC.,
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`·5· · · · · · · · · · · · ·Petitioner,
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`·6· · · · · -against-
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`·7· ·UNITED THERAPEUTICS CORPORATION,
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`·8· · · · · · · · · · · · ·Patent Owner.
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`·9· ·----------------------------------------x
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`10· · · · · · · · · · · · Case IPR2021-00406
`· · · · · · · · · · ·U.S. Patent No. 10,716,793B2
`11
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`12
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`13· · · · · · · · · ·STENOGRAPHIC DEPOSITION OF:
`· · · · · · · · · · · · NICHOLAS S. HILL, M.D.
`14· · · · · · · · · · Wednesday, April 13, 2022
`· · · · · · · · · · · · 9:02 a.m. - 10:38 a.m.
`15· · · · · · Reported Remotely through Videoconference
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`22· · · · · · · · · Reported stenographically by:
`· · · · · · · · · Richard Germosen, CA CSR No. 14391
`23· · · · · · RDR, CRR, CCR, CRCR, CSR-CA, NYACR, NYRCR
`· · · · · · · NCRA/NJ/NY/CA Certified Realtime Reporter
`24· · · · · · · ·NCRA Realtime Systems Administrator
`· · · · · · · · · · · · · ·Job No. 10098793
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`IPR2021-00406
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`·1· · · · · TELECONFERENCED STENOGRAPHIC DEPOSITION of
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`·2· ·NICHOLAS S. HILL, M.D., taken in the above-entitled
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`·3· ·matter before RICHARD GERMOSEN, Certified Court
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`·4· ·Reporter, (License No. 30XI00184700), Certified Realtime
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`·5· ·Court Reporter-NJ, (License No. 30XR00016800),
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`·6· ·California Certified Shorthand Reporter, (License No.
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`·7· ·14391), NCRA/NY/CA Certified Realtime Reporter, NCRA
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`·8· ·Registered Diplomate Reporter, New York Association
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`·9· ·Certified Reporter, NCRA Realtime Systems Administrator,
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`10· ·taken via remote video teleconference on Wednesday,
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`11· ·April 13, 2022, commencing at 9:02 a.m.
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`·1· ·A P P E A R A N C E S:
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`·2
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`·4· ·McDERMOTT WILL & EMERY LLP
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`·5· ·BY:· ARTHUR P. DYKHUIS, ESQ.
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`·6· ·18565 Jamboree Road
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`·7· ·Suite 250
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`·8· ·Irvine, California 92612-2565
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`·9· ·(949) 757.6398 / (949) 851.9348 (FAX)
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`10· ·adykhuis@mwe.com
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`11· ·Attorneys for the Plaintiff
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`12
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`13· ·McDERMOTT WILL & EMERY LLP
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`14· ·BY:· JOSHUA REVILLA, ESQ.
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`15· ·500 North Capitol Street, N.W.
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`16· ·Washington, D.C. 20001-1531
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`17· ·(202) 756.8938 / (202) 591.2975 (FAX)
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`18· ·jrevilla@mwe.com
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`19· ·Attorneys for the Plaintiff
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`·1· ·A P P E A R A N C E S:· (CONT'D.)
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`·2
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`·3
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`·4· ·COOLEY LLP
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`·5· ·BY:· JONATHAN DAVIES, ESQ.
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`·6· ·1299 Pennsylvania Avenue, N.W.
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`·7· ·Suite 700
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`·8· ·Washington, D.C. 20004
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`·9· ·(202) 842.7800 / (202) 842.7899 (FAX)
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`10· ·jdavies@cooley.com
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`11· ·Attorneys for the Defendant,
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`12· ·Liquidia Technologies, Inc.
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`13
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`14· ·COOLEY LLP
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`15· ·BY:· DEEPA KANNAPPAN, ESQ.
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`16· ·3175 Hanover Street
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`17· ·Palo Alto, California 94304-1130
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`18· ·(650) 843.5000 / (650) 849.7400 (FAX)
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`19· ·dkannappan@cooley.com
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`20· ·Attorneys for the Defendant,
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`21· ·Liquidia Technologies, Inc.
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`22
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`23· ·ALSO PRESENT:
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`24· ·AARON ISAACS, Document Technician
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`·1· · · · · · · · · · · · · · I N D E X
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`·2· ·WITNESS· · · · · · · · · · · · · · · · EXAMINATION
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`·3· ·NICHOLAS S. HILL, M.D.
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`·4· · ·BY MR. DYKHUIS· · · · · · · · · · · · · · · ·8
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`·5· · ·BY MR. DAVIES· · · · · · · · · · · · · · · ·43
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`·6· · ·BY MR. DYKHUIS· · · · · · · · · · · · · · · 46
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`·7
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`·9· · · · · · · · · · · · ·E X H I B I T S
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`10· ·EXHIBIT NO.· · DESCRIPTION· · · · · · · · · · PAGE
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`11· ·Exhibit 1106· ·document previously marked· · · 12
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`12· · · · · · · · · Exhibit 1106
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`13
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`14· ·Exhibit 1087· ·document previously marked· · · 25
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`15· · · · · · · · · Exhibit 1087
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`16
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`17· ·Exhibit 1086· ·document previously marked· · · 26
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`18· · · · · · · · · Exhibit 1086
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`19
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`20· ·Exhibit 1034· ·document previously marked· · · 32
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`21· · · · · · · · · Exhibit 1034
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`·1· · · · · · · · · ·E X H I B I T S· (CONT'D.)
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`·2· ·EXHIBIT NO.· · DESCRIPTION· · · · · · · · · · PAGE
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`·3· ·Exhibit 1008· ·document previously marked· · · 39
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`·4· · · · · · · · · Exhibit 1008
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`·5· ·**original exhibits returned with original transcript
`· · ·by APTUS COURT REPORTING to
`·6· ·McDERMOTT WILL & EMERY LLP
`· · ·(exhibit index concluded)
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`·1· ·--------------------------------------------------
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`·2· · · · · · · · · · · P R O C E E D I N G S
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`·3· · · · · · · · · · · · · · 9:02 a.m.
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`·4· ·--------------------------------------------------
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`·5· · · · · · · · · CERTIFIED STENOGRAPHER:· We're on the
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`·6· ·stenographic record at 9:02 a.m.
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`·7· · · · · · · · · Good morning.· My name is Rich
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`·8· ·Germosen.· I am a certified stenographic reporter.
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`·9· ·My license is available for inspection.
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`10· · · · · · · · · Do all parties stipulate to the
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`11· ·validity of this remote swearing and that it will be
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`12· ·admissible in the courtroom as if it had been taken
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`13· ·following Rule 30 of the Federal Rules of Civil
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`14· ·Procedure and the state's rules where this case is
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`15· ·pending?
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`16· · · · · · · · · MR. DAVIES:· Liquidia does.
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`17· · · · · · · · · MR. DYKHUIS:· Yes for United
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`18· ·Therapeutics.
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`19· · · · · · · · · (Whereupon, the Certified Realtime
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`20· ·Stenographer administered the oath to the witness.)
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`21
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`22· ·N I C H O L A S· ·S.· ·H I L L,· ·M.D.,
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`23· ·having been first duly sworn or affirmed, was
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`24· ·examined and testified as follows:
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`25· ·EXAMINATION BY MR. DYKHUIS:
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`·1· ·BY MR. DYKHUIS:
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`·2· · · · · Q.· · · Good morning, Dr. Hill.
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`·3· · · · · A.· · · Good morning.· Do I pronounce your
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`·4· ·name -- is it Dykhuis?
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`·5· · · · · Q.· · · Dykhuis.
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`·6· · · · · A.· · · Dykhuis.
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`·7· · · · · Q.· · · Right.
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`·8· · · · · A.· · · Dutch.
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`·9· · · · · Q.· · · Exactly.
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`10· · · · · A.· · · Yeah.
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`11· · · · · Q.· · · Exactly.
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`12· · · · · · · · · Well, thanks for making some time for
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`13· ·us this morning.
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`14· · · · · · · · · Could you just state your full name
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`15· ·and your location for the record, sir.
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`16· · · · · A.· · · Yes.· Nicholas S. Hill, M.D., located
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`17· ·in Boston, Massachusetts.
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`18· · · · · Q.· · · And are you at your office right now?
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`19· · · · · A.· · · Yes, I am.
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`20· · · · · Q.· · · And I can see behind you, but it
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`21· ·doesn't look like anyone else is there in the room
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`22· ·with you; is that correct?
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`23· · · · · A.· · · That's correct.
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`24· · · · · Q.· · · Do you have any open lines of
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`25· ·communication or chats or other devices,
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`·1· ·communications devices with you?
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`·2· · · · · A.· · · I have my phone, which is turned off.
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`·3· · · · · Q.· · · Do you have any documents with you
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`·4· ·this morning?
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`·5· · · · · A.· · · I do.· I have a printed copy of
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`·6· ·the -- my reply declaration.· Let's see if there is
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`·7· ·a date on this.· Well, it's my reply declaration.
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`·8· · · · · Q.· · · Okay.· Anything else besides the
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`·9· ·reply declaration?
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`10· · · · · A.· · · No.
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`11· · · · · Q.· · · Are there any markings or notes,
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`12· ·annotations on that document?
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`13· · · · · A.· · · I copied down the password for
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`14· ·this -- for this Zoom call, but that's it.
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`15· · · · · Q.· · · So some ground rules you've heard
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`16· ·before.· First, you understand, Dr. Hill, even
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`17· ·though this is a deposition conducted remotely,
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`18· ·you're under the same oath here as if you would be
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`19· ·in court; correct?
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`20· · · · · A.· · · I understand that.
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`21· · · · · Q.· · · And especially since we're talking
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`22· ·through Zoom, please speak clearly for the court
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`23· ·reporter and not too quickly; is that fair?
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`24· · · · · A.· · · That's fair.
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`25· · · · · Q.· · · I will -- if you don't understand a
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`·1· ·question, please tell me, but if you answer, I'll
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`·2· ·assume that you have understood the question.
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`·3· · · · · · · · · Do you understand that?
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`·4· · · · · A.· · · Yes, I do.
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`·5· · · · · Q.· · · Normally, I take breaks about every
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`·6· ·hour or so.· Today we have, I think, a shorter
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`·7· ·deposition, but as the day goes on, if you need a
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`·8· ·break, please let me know.· If there is a question,
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`·9· ·we just need an answer to that first, okay?
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`10· · · · · A.· · · Yes.
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`11· · · · · Q.· · · Is there any reason you're unable to
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`12· ·give full, true, and accurate testimony today?
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`13· · · · · A.· · · There is not.
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`14· · · · · Q.· · · How did you prepare for today's
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`15· ·deposition, Dr. Hill?
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`16· · · · · A.· · · I briefly reviewed some of the
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`17· ·documents relevant to today in concluding my reply
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`18· ·declaration, which is in front of me, and a rebuttal
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`19· ·report prepared by -- I can't remember who -- who
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`20· ·prepared it frankly, but rebuttal report on -- in
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`21· ·response to my reply.
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`22· · · · · Q.· · · A rebuttal report in response to your
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`23· ·reply declaration.· Did I hear that right?
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`24· · · · · A.· · · Yes.
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`25· · · · · Q.· · · Okay.· Do you know if that report was
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`·1· ·a District Court litigation document or an IPR
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`·2· ·declaration or brief document?
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`·3· · · · · A.· · · You know, I'm not entirely certain.
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`·4· ·Let's see.· I can try to see if I can find it.· It
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`·5· ·might take me a while to find it.· It's somewhere on
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`·6· ·my hard drive, but I don't know exactly where it is
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`·7· ·right now.
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`·8· · · · · Q.· · · Understood.· Okay.
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`·9· · · · · · · · · Was it a document from either
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`10· ·Dr. Waxman or Dr. McConville?
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`11· · · · · A.· · · I'm not certain.· Sorry.
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`12· · · · · Q.· · · Okay.· What else did you do besides
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`13· ·review your report, your reply declaration, and
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`14· ·this -- call it the unknown report?
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`15· · · · · A.· · · Yeah, I apologize for that.· I went
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`16· ·over some of the preparations with Attorney Davies,
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`17· ·Cazakoff, and let's see, Deepa.· I'll get her last
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`18· ·name in a second.· Kannappan, K-a-n-n-a-p-p-a-n.
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`19· · · · · Q.· · · And when did you meet in preparation
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`20· ·with those attorneys?
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`21· · · · · A.· · · We met by virtually yesterday
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`22· ·afternoon starting at approximately 3 p.m. and
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`23· ·ending at approximately 6 p.m.
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`24· · · · · Q.· · · Any other preparation besides that
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`25· ·meeting yesterday and the review of the reply
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`·1· ·declaration and the other report?
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`·2· · · · · A.· · · We met briefly this morning,
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`·3· ·Mr. Davies and Ms. Cazakoff and I, between 8:30 and
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`·4· ·just before we got on this call.
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`·5· · · · · · · · · MR. DYKHUIS:· Mr. Isaacs, let's share
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`·6· ·exhibit 1106, please.
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`·7· · · · · · · · · (Whereupon, document previously
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`·8· ·marked Exhibit 1106, is received and marked as
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`·9· ·Exhibit 1106 for Identification.)
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`10· · · · · · · · · CERTIFIED STENOGRAPHER:· Counsel, is
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`11· ·this a fresh document?
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`12· · · · · · · · · MR. DYKHUIS:· This is already an
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`13· ·exhibit in the IPR, but it's -- it's exhibit 1106.
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`14· · · · · · · · · MR. DAVIES:· And, counsel, if we can
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`15· ·also -- oh, sorry.· That's been entered in the chat.
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`16· · · · · · · · · MR. DYKHUIS:· Yes.
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`17· ·BY MR. DYKHUIS:
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`18· · · · · Q.· · · Dr. Hill, you see there is the Zoom
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`19· ·chat feature?· It's got a link to Box.com document.
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`20· ·Just let me know if you can look at it either way,
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`21· ·either on the shared screen or through that link,
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`22· ·and just let me know when you're ready.
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`23· · · · · A.· · · Okay.· Well, for right now, I'll use
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`24· ·the shared screen if that's all right.
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`25· · · · · Q.· · · Okay.· Yes, that's fine.
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`·1· · · · · · · · · I just wanted to ask you:· Do you
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`·2· ·recognize this as your reply declaration submitted
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`·3· ·in the IPR?
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`·4· · · · · A.· · · Yes.
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`·5· · · · · Q.· · · Thank you.
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`·6· · · · · · · · · And is this the same document as you
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`·7· ·have printed in hard copy in front of you?
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`·8· · · · · A.· · · Yes, it is.
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`·9· · · · · Q.· · · Okay.· And then the last page that's
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`10· ·numbered as page 85, is that your signature signed
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`11· ·on February 10, 2022?
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`12· · · · · A.· · · Yes, it is.
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`13· · · · · Q.· · · And so everything in this declaration
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`14· ·is true and correct in your opinion?
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`15· · · · · A.· · · To the best of my knowledge, yes.
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`16· · · · · Q.· · · So let's go to paragraph 21, please.
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`17· ·Actually, let's stop short of that and stop at
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`18· ·paragraph 16 first.
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`19· · · · · A.· · · Okay.· I have paragraph 16.
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`20· · · · · Q.· · · I'm sorry, I'm misdirecting us twice
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`21· ·in a row now.· Paragraph nine I meant.
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`22· · · · · A.· · · Okay.
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`23· · · · · Q.· · · Feel free to look at the screen or
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`24· ·the print copy or the one in the link.
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`25· · · · · · · · · Paragraph 9 includes a table listing
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`·1· ·exhibit numbers and description of documents.
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`·2· · · · · · · · · Do you see that?
`
`·3· · · · · A.· · · Yes, I do.
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`·4· · · · · Q.· · · And it continues on a few pages
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`·5· ·through page seven?
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`·6· · · · · A.· · · Yes, it does.
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`·7· · · · · Q.· · · And those are the materials that you
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`·8· ·reviewed and considered in preparing the opinions in
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`·9· ·this reply declaration; is that correct?
`
`10· · · · · A.· · · That's correct.
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`11· · · · · Q.· · · Okay.· Now we can go to paragraph 21,
`
`12· ·please.
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`13· · · · · A.· · · Okay.· I'm on the paragraph 21.
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`14· · · · · Q.· · · And in paragraph 21, you are talking
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`15· ·about a document called the Voswinckel JAHA or
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`16· ·Voswinckel JAHA; correct?
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`17· · · · · A.· · · That's correct.
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`18· · · · · Q.· · · That's exhibit 1008?
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`19· · · · · A.· · · Yes.
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`20· · · · · Q.· · · And then in the second to last line
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`21· ·of -- I'll exclude the footnote, but second to last
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`22· ·line on the page here in paragraph 21, you refer to
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`23· ·Scientific Sessions 2004 conference.
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`24· · · · · · · · · Do you see that?
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`25· · · · · A.· · · Yes, I do.
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`·1· · · · · Q.· · · And then it's Scientific Sessions
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`·2· ·2004 conference, well, in November of 2004?
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`·3· · · · · A.· · · Yes.
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`·4· · · · · Q.· · · You did not personally attend that
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`·5· ·conference; correct?
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`·6· · · · · A.· · · I don't recall attending it, no.
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`·7· · · · · Q.· · · And then if we jump ahead to
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`·8· ·paragraph 28, there you're talking about a reference
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`·9· ·called Voswinckel JESC or Voswinckel JESC.
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`10· · · · · · · · · Are you there?
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`11· · · · · A.· · · Yes, I am.
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`12· · · · · Q.· · · Thank you.
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`13· · · · · · · · · In this one, you reference a European
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`14· ·Society of Cardiology or ESC conference?
`
`15· · · · · A.· · · Yes, I do.
`
`16· · · · · Q.· · · And you didn't personally attend that
`
`17· ·one either; correct?
`
`18· · · · · A.· · · That's correct.
`
`19· · · · · Q.· · · Let's go back, if we could, to
`
`20· ·paragraph 22.· Sorry to jump around or jump back and
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`21· ·forth.
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`22· · · · · A.· · · No problem.· Keeps me on my toes.
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`23· · · · · · · · · Okay.· I'm at paragraph 22.
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`24· · · · · Q.· · · Paragraph 22 towards the end, the
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`25· ·last line you mention Ms. Wyman's opinions, and then
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`·1· ·the sentence continues onto the next page, page 14,
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`·2· ·and you have a citation that says:· See exhibit
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`·3· ·2041, Wyman declaration.
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`·4· · · · · · · · · Do you see that citation?
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`·5· · · · · A.· · · Yes, I do.
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`·6· · · · · Q.· · · And in the parenthetical you say:
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`·7· ·Stating without evidence that a POSA conducting
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`·8· ·diligent research would not sift through such
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`·9· ·voluminous results.
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`10· · · · · · · · · Do you see that language?
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`11· · · · · A.· · · Yes, I do.
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`12· · · · · Q.· · · And then why does it matter to you
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`13· ·that in your view, the assertion here was made,
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`14· ·quote/unquote, without evidence?
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`15· · · · · · · · · MR. DAVIES:· Objection.· Form.
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`16· · · · · · · · · You can answer.
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`17· · · · · A.· · · Would it be possible to pull up the
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`18· ·Wyman declaration?
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`19· · · · · Q.· · · We can.· It might take a moment.· We
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`20· ·might have to loop back to it, because I don't know
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`21· ·if I have that one handy, but I guess I'm not
`
`22· ·expecting to get into a lot of detail here.· I just
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`23· ·wanted to see what is the significance, if any, to
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`24· ·you, and why did you think it important to note that
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`25· ·Ms. Wyman did something that was in your view
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`·1· ·stated, quote/unquote, without evidence?
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`·2· · · · · · · · · MR. DAVIES:· The same objection.
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`·3· · · · · A.· · · The direct quote from the declaration
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`·4· ·is that:· A POSA conducting diligent research
`
`·5· ·wouldn't sift through such voluminous results.
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`·6· · · · · · · · · So Ms. Wyman is expressing the
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`·7· ·opinion that a POSA would not look at these results
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`·8· ·and, in fact, this is not backed up by evidence. I
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`·9· ·think it's just a number of things that would
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`10· ·undermine this opinion.
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`11· · · · · Q.· · · Let's jump ahead to paragraph 24.
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`12· · · · · A.· · · Okay.· I'm there.
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`13· · · · · Q.· · · Let me just clarify your previous
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`14· ·answer.· I think what I heard is if the opinion is
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`15· ·not backed up by evidence, that undermines the
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`16· ·opinion in your view.· Was that correct?
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`17· · · · · A.· · · That's correct.
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`18· · · · · · · · · MR. DAVIES:· Objection to the form.
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`19· · · · · Q.· · · Okay.· So then in paragraph 24, the
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`20· ·fourth line in the body, not the footnote, but the
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`21· ·fourth line from the bottom in paragraph 24, you're
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`22· ·talking about the Voswinckel JAHA reference, and
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`23· ·then the second to last line -- well, you mention
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`24· ·that you have been provided with stamped copies of
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`25· ·Voswinckel JAHA.
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`·1· · · · · · · · · Do you see that?
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`·2· · · · · A.· · · Yes.
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`·3· · · · · Q.· · · And then you were provided with those
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`·4· ·copies, stamped copies were provided by counsel;
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`·5· ·correct?
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`·6· · · · · A.· · · That's correct.
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`·7· · · · · Q.· · · You say in the second to last line:
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`·8· ·I have been informed that the stamps on these copies
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`·9· ·of Voswinckel JAHA indicate that Voswinckel JAHA was
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`10· ·disseminated and accessible by the stamp date.
`
`11· · · · · · · · · Did I read that correctly?
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`12· · · · · A.· · · You did.
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`13· · · · · Q.· · · And so there when you say you have
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`14· ·been informed, you're referring to you being
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`15· ·informed by counsel; correct?
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`16· · · · · A.· · · Yes.
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`17· · · · · Q.· · · Other than the bare statement in this
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`18· ·sentence that the stamps on these copies, excuse me,
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`19· ·copies indicate that JAHA was disseminated and
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`20· ·accessible, did counsel instruct you further on the
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`21· ·meaning of the stamps?
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`22· · · · · · · · · MR. DAVIES:· Objection to the form.
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`23· · · · · A.· · · I don't recall that, no.
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`24· · · · · Q.· · · So in that respect, this statement
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`25· ·here, this sentence is a full statement of your
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`·2· · · · · A.· · · And let's just be specific about what
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`·3· ·statement -- the beginning:· I haven't been
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`·4· ·informed, and then finishing where?
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`·5· · · · · Q.· · · The sentence I read before, starting
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`·6· ·with:· I have been informed, and then ending on page
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`·7· ·16, the sentence ends with:· By the stamp date.
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`·8· · · · · A.· · · And the question was?
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`·9· · · · · Q.· · · Is that -- the question was:· Is this
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`10· ·sentence stating that stamps on copies of JAHA
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`11· ·indicate it was disseminated and accessible by the
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`12· ·stamp date, is that a full statement of everything
`
`13· ·that counsel informed you of regarding the meaning
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`14· ·of the stamps?
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`15· · · · · · · · · MR. DAVIES:· Objection.· Form.
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`16· · · · · A.· · · As I recall, yes.
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`17· · · · · Q.· · · Looking at -- staying in paragraph
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`18· ·24, but on page 16, the next sentence after the one
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`19· ·we've been looking at says:· One of the stamped
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`20· ·copies was stamped with a 10/2004 date indicating it
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`21· ·was available before the date of the conference, and
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`22· ·you go on and say:· The stamp further indicates the
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`23· ·abstract was available well before May 15, 2006.
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`24· · · · · · · · · Those two sentences are based on your
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`25· ·understanding from counsel on the meaning of the
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`·1· ·stamps; correct?
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`·2· · · · · · · · · MR. DAVIES:· Objection.· Form.
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`·3· · · · · A.· · · Well, yes, and, you know, my
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`·4· ·experience attending many of these conferences, the
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`·5· ·conferences compile these abstract issues that are
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`·6· ·generally disseminated as a supplement to the
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`·7· ·journal to the subscribers and also are available at
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`·8· ·the meeting site.· At the start of the meeting, you
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`·9· ·can register and you can pick up the abstract
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`10· ·supplements in a print form, and you can look
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`11· ·through them before the abstract sessions so you can
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`12· ·plan out what abstracts you're going to visit, but,
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`13· ·you know, what I was told is consistent with my
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`14· ·experience in attending these meetings.· This is how
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`15· ·these abstracts are handled.
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`16· · · · · Q.· · · Okay.· Thank you.
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`17· · · · · · · · · And if we go to paragraph 31, please.
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`18· ·And on actually paragraph 31, the end of it.· So on
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`19· ·page 23 and then the third line from the top, about
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`20· ·halfway through it says:· I have been informed that
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`21· ·the stamped copies indicate that copies of
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`22· ·Voswinckel JESC were received by a library.
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`23· · · · · · · · · Do you see that text, Dr. Hill?
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`24· · · · · A.· · · Yes, I do.
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`25· · · · · Q.· · · And again, when you say:· I have been
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`·1· ·informed, that's information with respect to
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`·2· ·Voswinckel JESC information from counsel again;
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`·3· ·correct?
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`·4· · · · · A.· · · Yes.
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`·5· · · · · Q.· · · And let's go to paragraph 33, please.
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`·6· · · · · A.· · · I'm there.
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`·7· · · · · Q.· · · The fifth line starts with:· I am
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`·8· ·informed by counsel that undergoing the peer review
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`·9· ·process is not a prerequisite for a reference to
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`10· ·qualify as prior art.
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`11· · · · · · · · · Do you see that?
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`12· · · · · A.· · · Yes, I do.
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`13· · · · · Q.· · · This is another understanding of
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`14· ·yours from counsel for Liquidia; correct?
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`15· · · · · A.· · · Yes, it is.
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`16· · · · · Q.· · · And then in paragraph 33, you mention
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`17· ·this because -- well, you agree that Voswinckel JESC
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`18· ·and Voswinckel JAHA did not go through the normal
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`19· ·peer review process that a full-blown or a normal
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`20· ·journal article would; correct?
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`21· · · · · A.· · · That's true.
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`22· · · · · Q.· · · Let's go, please, to paragraph 61.
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`23· · · · · · · · · MR. DAVIES:· I'm sorry, you said 61?
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`24· · · · · · · · · MR. DYKHUIS:· Yeah, paragraph 61.
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`25· · · · · · · · · MR. DAVIES:· Thank you.
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`·1· · · · · A.· · · Okay.· I'm there.
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`·2· ·BY MR. DYKHUIS:
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`·3· · · · · Q.· · · I think it's about seven lines up
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`·4· ·from the bottom on page 52, in paragraph 61, towards
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`·5· ·the right there is a sentence that says:· In my
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`·6· ·clinical experience, the average nebulization rate
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`·7· ·for continuous nebulizers in the 2006 time frame was
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`·8· ·0.5 to 0.6 milliliters per minute.
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`·9· · · · · · · · · Did I read that correctly, Dr. Hill?
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`10· · · · · A.· · · You did.
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`11· · · · · Q.· · · And that is your sworn testimony in
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`12· ·this declaration?
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`13· · · · · A.· · · Yes, it is.
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`14· · · · · Q.· · · And what you cite there as exhibit
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`15· ·1037 at page 28; correct?
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`16· · · · · A.· · · That's correct.
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`17· · · · · Q.· · · And the parenthetical cites exhibit
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`18· ·1037 as disclosing a nebulizing rate of 0.6
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`19· ·milliliters per minute?
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`20· · · · · A.· · · Yes, that's correct.
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`21· · · · · Q.· · · And earlier, we looked at the list of
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`22· ·materials you consider, but exhibit 1037 is what you
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`23· ·describe as an English translation for OptiNeb user
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`24· ·annual 2005; is that right?
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`25· · · · · A.· · · That's correct.
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`·1· · · · · Q.· · · So in paragraph -- excuse me,
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`·2· ·paragraph 61, the evidence you cite for the 0.6 rate
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`·3· ·is the exhibit 1037 English translation OptiNeb user
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`·4· ·manual 2005?
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`·5· · · · · · · · · MR. DAVIES:· Objection.· Form.
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`·6· · · · · A.· · · Yes, and including my clinical
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`·7· ·experience.
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`·8· · · · · Q.· · · And you don't cite there in paragraph
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`·9· ·61 a separate document that specifically discloses a
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`10· ·nebulizing rate of 0.5 milliliters per minute?
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`11· · · · · A.· · · I don't believe so, no.
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`12· · · · · Q.· · · Let's jump ahead to paragraph 63.
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`13· · · · · A.· · · Okay.· I'm there.
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`14· · · · · Q.· · · And I'm looking at the portion of it
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`15· ·that's on page 54.
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`16· · · · · A.· · · Okay.
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`17· · · · · Q.· · · You say:· In fact, it appears almost
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`18· ·certain that the nebulized volume in Voswinckel JESC
`
`19· ·was 3.6 milliliters over the six minutes of
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`20· ·administration since the manual cites 0.6
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`21· ·milliliters per minute as the nebulization rate, and
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`22· ·then in your citations you refer to:· See also
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`23· ·exhibit 1037.
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`24· · · · · · · · · Do you see that, Dr. Hill?
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`25· · · · · A.· · · Yes, I do.
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`·1· · · · · Q.· · · And so again, you rely on the 0.6
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`·2· ·number on exhibit 1037 to calculate a volume of 3.6
`
`·3· ·milliliters over six minutes; correct?
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`·4· · · · · A.· · · That's how that calculation was made,
`
`·5· ·yes.
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`·6· · · · · Q.· · · And then if we just go one paragraph
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`·7· ·previous to number 62.
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`·8· · · · · A.· · · Okay.
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`·9· · · · · Q.· · · There you are -- you state:· It's
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`10· ·wrong to characterize the OptiNeb manual as undated,
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`11· ·and I'm paraphrasing, but the basis is counsel
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`12· ·informs me that Liquidia submitted an affidavit from
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`13· ·Christopher Butler attesting to the date of the
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`14· ·OptiNeb user manual, thereby establishing its date.
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`15· · · · · · · · · Do you see that language in paragraph
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`16· ·62?
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`17· · · · · A.· · · Yes, I do.
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`18· · · · · Q.· · · And you cite exhibit 1087, which is a
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`19· ·declaration from Christopher Butler; is that
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`20· ·correct?
`
`21· · · · · A.· · · Yes.
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`22· · · · · Q.· · · And this is an instance again where
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`23· ·counsel informed you that the Butler declaration
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`24· ·establishes the date of the OptiNeb manual?
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`25· · · · · A.· · · That's correct.
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`·1· · · · · Q.· · · Did you -- did you review exhibit
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`·2· ·1087 before signing this declaration?
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`·3· · · · · A.· · · I believe I did.· I don't recall with
`
`·4· ·certainty.
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`·5· · · · · · · · · MR. DYKHUIS:· Mr. Isaacs, can we
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`·6· ·share exhibit 1087, please.
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`·7· · · · · · · · · (Whereupon, document previously
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`·8· ·marked Exhibit 1087, is received and marked as
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`·9· ·Exhibit 1087 for Identification.)
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`10· ·BY MR. DYKHUIS:
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`11· · · · · Q.· · · Again, Dr. Hill, you'll see -- I
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`12· ·mean, it's up on the screen, at least the top of the
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`13· ·first page, and then it's also available in the chat
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`14· ·if you'd like to have your own copy.
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`15· · · · · A.· · · I'll use the one on the screen.
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`16· · · · · Q.· · · Okay.· Okay.· And if -- I think,
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`17· ·Mr. Isaacs, let us know if you want control of it.
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`18· ·Well, let's show the bottom of the screen or the
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`19· ·bottom of that first page there.· It identifies this
`
`20· ·as -- well, it says affidavit of Christopher Butler
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`21· ·at the top, and below it's Liquidia's exhibit 1087.
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`22· · · · · · · · · Do you see that, Dr. Hill?
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`23· · · · · A.· · · Yes, I do.
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`24· · · · · Q.· · · Do you recognize this now, at least
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`25· ·looking at the first page, as exhibit 1087?
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`·1· · · · · A.· · · It looks familiar.
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`·2· · · · · Q.· · · Okay.· Does that remind you whether
`
`·3· ·you had previously reviewed this document?
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`·4· · · · · A.· · · I think I did.
`
`·5· · · · · Q.· · · And on page 12, there is a title for
`
`·6· ·exhibit E, and then the following page there is a
`
`·7· ·color image that appears to be a German language
`
`·8· ·document.
`
`·9· · · · · · · · · Do you see that, Dr. Hill?
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`10· · · · · A.· · · Yes, I do.
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`11· · · · · Q.· · · Did you review before signing your
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`12· ·declaration this German language document beginning
`
`13· ·at page 12 or so of exhibit 1087?
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`14· · · · · A.· · · I don't recall doing that.· I have no
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`
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